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EPA May Allow Pesticide & Chemical Experiments on Children & Adults

>From the Environmental News Service

http://www.ens-newswire.com/ens/feb2005/2005-02-08-10.asp

EPA Avoids Regulation of Chemical Experiments on Humans

WASHINGTON, DC, February 8, 2005 (ENS) - Experiments that intentionally
dose human subjects with pesticides and other chemicals will be evaluated
and approved by the U.S. Environmental Protection Agency (EPA) in a wide
open case-by-case manner, the agency says in a draft notice for publication
in the Federal Register.

The EPA is seeking public comment on this case-by-case method of
considering experiments that involve human subjects in a notice dated
February 2 and signed by Susan Hazen, acting assistant administrator in the
Office of Prevention, Pesticides and Toxic Substances.

The guidelines proposed by the agency are all voluntary and non-binding
upon the experimenters, the EPA or the public.

There are no legally binding regulations on the intentional dosing of
pregnant women with chemicals for experiments. (Photo credit unknown)
The notice defers adopting legally binding protections for infants,
fetuses, pregnant women, and prisoners that apply to all medical and drug
testing overseen by the Department of Health and Human Services (HHS).
Instead, EPA announces that it "indends to publish a proposed rule" at some
time in the future.

The EPA says it "may propose to adopt some or all of the HHS regulations
that provide additional protections for certain populations of vulnerable
subjects." This proposal "may" require a sponsor or investigator to provide
the protocol for the human studies to the EPA for prior review and approval.

In the notice, the EPA says its overall goals are, "That human participants
in any research required by, conducted for, or considered by EPA are treated
ethically; and that all scientifically sound data relevant to EPA
decision-making is considered and used appropriately in reaching decisions
under our authorities."

But the attorney who heads a national association of natural resources
government employees says the agency¹s procedure lacks ethical or safety
guidelines. "EPA¹s stance is appallingly amoral," said Jeff Ruch, executive
director of Public Employees for Environmental Responsibility (PEER), which
made the notice public on Monday.

"At the request of chemical companies seeking to justify higher exposure
limits, EPA will sanction dosing of infants, pregnant women and other
vulnerable persons with commercial poisons," Ruch said.

After a heated public debate about intentional dosing human toxicity
studies with pesticides and several attempts at rulemaking, one of which
ended in a 2003 court ruling that sent the agency back to the drawing board,
the EPA is using this Federal Register notice to outline the case-by-case
procedure it is now using to evaluate such studies.

Rental housing for farm workers, Sebring, Florida. Children in homes like
this are proposed by the EPA for an experiment subjecting them to
intentional doses of pesticides. (Photo courtesy HUD)
The agency says that any research on human subjects conducted or supported
by the EPA is subject to the principles of the 1979 Belmont Report, known as
the Common Rule.

These principles include such basics as informed consent about the research
procedure, purposes, risks and anticipated benefits, and a statement
offering the subject the opportunity to ask questions and to withdraw at any
time from the research.

But third party studies, conducted by groups not supported by federal
money, are not subject to the Common Rule. The agency says it will continue
to accept scientifically valid third party studies unless there is "clear
evidence" that the studies were "fundamentally" unethical, that is, "the
studies were intended to seriously harm participants or failed to obtain
informed consent ..."

The agency said it intends to expand the functions of the EPA Human
Subjects Research Review Official (HSRRO). This official has responsibility
for assuring that all human subjects research conducted or supported by the
EPA complies with the requirements of the Common Rule.

Ruch says by giving the HSRRO this responsibility, the EPA avoids "any
requirement of an independent safety or ethical review, as is required for
all other government human subject studies."

Jeff Ruch, PEER executive director a founder of the organization, is a
former California deputy district attorney, and former counsel to California
legislative committees. (Photo courtesy PEER)
"In practice, Ruch says, "it will be up to the top political appointees to
flag unethical corporate experiments on a case-by-case basis."

The agency will not require that companies demonstrate that they have
abided by informed consent, appropriate inducement and other basic ethical
standards.

Instead, the EPA says it will at some future time, "develop and make public
a policy statement that encourages, but does not require," non-federal
researchers planning studies involving human participants to support an EPA
regulatory decision, to submit a proposed protocol to EPA prior to
conducting the research.

Also the EPA intends to publish a "non-binding guidance" explaining that
the agency expects compliance with the Common Rule for any future human
studies specifically required by the EPA.

The EPA says it intends to reach out to scientific journals encouraging
improved reporting of the ethics of published human studies.

The EPA case-by-case process allows wide latitude to scientists and
chemical companies. Any "stakeholder" may urge EPA to: "(1) Conclude that
this process is inapplicable; (2) consider factors other than those
described here; or (3) make an exception to the process as described."

EPA notes that based on individual circumstances it may decide to act
differently from the review process described in the Federal Register
notice. "Affected parties should not assume that EPA will follow a
prescribed method of reviewing a particular human study in each and every
instance," the agency writes.

The only requirement the agency says it will adhere to is that in any
action involving consideration and review of a third-party, intentional
dosing human study, EPA "will explicitly state the basis upon which such a
study has been evaluated."

"Since there are no public notice requirements," Ruch said, "the outside
world will never learn of ethically dubious corporate experiments." He
warned that many corporate studies will be done in developing countries,
inviting "chemical companies to push the outside of the moral envelope."

Vietnamese women and children. Although there has been little study of
whether high levels of insecticides in the environment are causing disease,
insecticide poisoning cases are common in Vietnam's hospitals, according to
a 1996 issue of "Environmental Health Perspectives," a government
publication. (Photo courtesy EHP)

Last November the EPA delayed its own controversial Children's Health
Environmental Exposure Risk Study (CHEERS) which would measure children's
exposure to pesticides in the home, to calm public concern generated by news
reports questioning whether the study conforms to ethical standards.

The EPA would pay 60 families nearly $1,000 each for involvement in the
two-year study.

Critics such as the Environmental Working Group and PEER say collecting
such human testing data unethically encourages study participants to be
exposed to toxic substances to allow industry to push for reduced regulatory
controls on pesticides and other chemicals.

The EPA is forming a panel to review the study. In a January 24 letter to
then EPA Deputy Administrator Stephen Johnson, the Environmental Working
Group requests that the makeup of the panel be "fair and balanced."

"By that we mean that there should be no past or present pesticide or
chemical industry employees, consultants or contractors on the review panel,
and that there must be several individuals with strong public health
credentials, including expertise in pediatric environmental health," wrote
Environmental Working Group Senior Vice President Richard Wiles.

EPA Acting Administrator Stephen Johnson (Photo courtesy EPA)
Johnson, who has defended the CHEERS study, has now been elevated to the
position of EPA Acting Administrator, following the departure of former EPA
Adminstrator Mike Leavitt January 28 to head the Department of Health and
Human Services.

Wiles notes that his organization and others object to the "fundamentally
unethical nature" of the CHEERS study design, which proposed to "stand by
and simply observe what the study acknowledged to be high pesticide
exposures to infants and small children."

The federal register notice, with its wide open non-binding guidelines
appears to be the agency's attempt to lay the groundwork for justifying
consideration of such human studies.

This draft notice is identical to an earlier draft of the EPA's approach to
human testing of chemical exposures. The first draft was withdrawn after
PEER publicly released it in late November. Ruch says this latest draft is
"identical in effect to the earlier draft" but specifies possible standards
that EPA may consider in the future.

Pesticide makers, who support human testing data as more reliable than
animal studies in developing accurate exposure limits, have been awaiting a
rule for years.

Quote of Note

"Become intimate with your own backyard, with a bit of riverbank, with a
pond or hill. The rest of the watershed, the meta-landscape, the continent,
planet and universe will be naturally drawn into this intimacy."
-- John McClellan, in "The Many Voices of the Boulder Creek Watershed"

Copyright Environment News Service (ENS) 2004. All Rights Reserved.